Genentech ML42439 (myTACTIC) ERBB2 TMB high

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm J: Trastuzumab emtansine plus atezolizumab in patients with ERBB2 amplification or mutation plus TMB-H/MSI-H/dMMR-positive tumors

NCT04632992

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage 4

Metastatic/Palliative

Any line

TD-M1 + atezolizumab

anti-HER2 agent and anti-PD-L1 agent

Genentech, Inc.

Phase 2

Closed to Accrual

• Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
• Positive biomarker results from a CLIA certified lab, either tissue or blood sample
• No breast cancer (breast cancer is excluded)
• Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
• Any of the following ERBB2 mutations:
  • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
• Must ALSO have one of the following alterations
  • ​TMB > or =10 mutations/megabase
  • MSI-h
  • dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
• ECOG PS 0-2
• No symptomatic CNS metastases
• No known HIV/HBV/HCV
• No other malignancy within 3 years of study
• No prior treatment with crizotinib
• No active autoimmune disease

• Primary-
  • ORR
• Secondary
  • PFS
  • DoR
  • OS
  • PFS at various time points
  • DCR
  • Safety

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ERBB amplificaiton or mutation AND TMB-h or MSI-h or dMMR

No